FDA recall D-1051-2019

Product

Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.

Reason for recall

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.

Distribution

California, Georgia, Indiana

Key facts

Status

Terminated

Initiation date

2019-03-06

Report date

2019-03-27

Termination date

2023-03-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1051-2019